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Registry EUDAMED ~303 FDA 510(k) ~82 FDA PMA GUDID ~15

Country / market European Union (all) ~274 United States ~97

More countries (18)

Germany ~51 Romania ~32 Czechia ~28 Poland ~25 Spain ~22 Denmark ~20 Netherlands ~18 Italy ~17 Norway ~13 Austria ~12 Sweden ~12 Türkiye ~10 France ~9 Greece ~8 Finland ~8 Portugal ~5 Lithuania ~4 Bulgaria ~2

Risk class Class I ~388 Class IIa ~12 Class IIb Class III Class II (US)

More classes (11)

Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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671 devices foundsorted by relevance

Manufacturer: Hartalega Sdn Bhd× Clear all

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Ilico Acf UDI-DI 08594202840615

Hartalega Ngc Sdn. Bhd.,Malaysia Class I

Active CE MDR EUDAMED I
5 variants
- Ilico Acf L
- Ilico Acf M
- Ilico Acf XL
- See all variants of this device
Bal Protect Nitril Pro Long Blue UDI-DI 19551025943073

Hartalega Ngc Sdn. Bhd.,Malaysia Class I

Active CE MDR EUDAMED I
5 variants
- Bal Protect Nitril Pro Long Blue 2618140302
- Bal Protect Nitril Pro Long Blue 2618140303
- Bal Protect Nitril Pro Long Blue 2618140304
- See all variants of this device
Ilico Pink UDI-DI 08594202840868

Hartalega Ngc Sdn. Bhd.,Malaysia Class I

Active CE MDR EUDAMED I
3 variants
- Ilico Pink M
- Ilico Pink S
Ilico Latex UDI-DI 08594202840325

Hartalega Ngc Sdn. Bhd.,Malaysia Class I

Active CE MDR EUDAMED I
5 variants
Ilico Nitrile UDI-DI 08594202840370

Hartalega Ngc Sdn. Bhd.,Malaysia Class I

Active CE MDR EUDAMED I
5 variants
- See all variants of this device
Ilico Bdg UDI-DI 08594202840509

Hartalega Ngc Sdn. Bhd.,Malaysia Class I

Active CE MDR EUDAMED I
5 variants
Iberian Care Sterile Nitrile Pf Exam Glove UDI-DI 09551025947555

Hartalega Ngc Sdn. Bhd.,Malaysia Class I

Active CE MDR EUDAMED I
5 variants
- See all variants of this device
Ilico Amg Pf UDI-DI 08594202840424

Hartalega Ngc Sdn. Bhd.,Malaysia Class I

Active CE MDR EUDAMED I
5 variants
- See all variants of this device

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